CoPainHell: The Analgesic Effect of Alcohol and Music

NCT06471985 | Completed DMC FDA Device

• 1 other identifier: CPH_2024
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

The study is a 2x2 randomized crossover study. Participants are randomized to listen to one of two music tracks: "Orinoco Flow" by Enya or "Raining Blood" by Slayer. Prior to the intervention, participants' breath alcohol levels are measured through a breathalyzer test. The intervention involves a cold water test, where the participant's dominant hand is submerged in water at 4-5 degrees Celsius. Participants are instructed to keep their hand in the water until the pain becomes too intense, but no longer than 5 minutes. Two hours after the first test, the same procedure is repeated, but participants listen to the other music track than they did during the first test. Participants receive no instructions on how to behave during the 2-hour interval. The experiment takes place during the music festival CopenHell (June 19-22, 2024), provided that there is approval from relevant authorities. Two hours after the first test, the same procedure is repeated, but participants listen to the other music track than in the first test. Participants are given no instructions on how to behave during the 2-hour interval.

Conditions

Acute Pain

Outcome Measures

Primary Outcomes (1)

• pain responsiveness

  Pain responsiveness will be measured on the VAS, where an investigator will ask the participants to rate their experienced pain from 1-10. The VAS will be rated at the start of CPT + 30 seconds, 60 seconds, 90, 120, 180, 240 and 300 seconds or when reaching the pain tolerance (up to 5 minutes), where the test will end whichever comes first. VAS: Visuel Analog Scale. Values 0-10, where 0 is no pain at al and 10 is the worst pain imaginable

  300 seconds

Secondary Outcomes (1)

• pain threshold and pain tolerance

  five minutes

Study Arms (2)

Enya + Pain test

ACTIVE COMPARATOR

In this arm, participants will listen to Enya in headphones while being exposed to the Cold Pressor Test.

Combination Product: Music and pain

Slayer + Pain test

ACTIVE COMPARATOR

In this arm, participants will listen to Slayer in headphones while being exposed to the Cold Pressor Test.

Combination Product: Music and pain

Interventions

Music and pain COMBINATION_PRODUCT

In both arms of the study the participant will take the same pain test. They will either listen to Enya or slayer, depending on the arm

Enya + Pain test; Slayer + Pain test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants ≥ 18 years old
• Informed consent
• Breath alcohol concentration ranging from 0.0 to 1.5 permille and deemed fit by the investigator at the time of giving informed consent

You may not qualify if:

• Wounds on dominant arm
• Current illness (a flu, cold etc.)
• Persons with diabetes because of the risk of peripheral neuropathies or other know peripheral sensibility paresthesia
• Circulation issues (especially Raynaud's syndrome)
• Pregnancy
• Pull-out criteria
• \- Breath alcohol concentration \> 2.5 permille and/or deemed unfit to participate by the investigator at the second pain test

Sponsors & Collaborators

• Eske Kvanner Aasvang: lead

Study Sites (1)

Copenhell metal Festival

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Acute Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Eske K Aasvang

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 18, 2024
• First Posted: June 24, 2024
• Study Start: June 19, 2024
• Primary Completion: June 22, 2024
• Study Completion: December 31, 2024
• Last Updated: April 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)